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Ziprasidone vs Standard Therapy for Agitated Patients in the ED

NCT ID: NCT00786318

Last Updated: 2017-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2011-07-31

Brief Summary

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The primary objective is to determine if ziprasidone is superior to standard therapies in the emergency department treatment of the acutely agitated patient. The primary outcome will be the length of time taken until the patient is ready to be evaluated by the psychiatric service, or until a disposition is made.

Detailed Description

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Conditions

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Psychosis Agitation Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ziprasidone

Group Type EXPERIMENTAL

ziprasidone

Intervention Type DRUG

ziprasidone 20mg IM

Standard therapy

Group Type ACTIVE_COMPARATOR

Standard therapy

Intervention Type DRUG

Haldol 5mg/ Ativan 2mg IM

Interventions

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ziprasidone

ziprasidone 20mg IM

Intervention Type DRUG

Standard therapy

Haldol 5mg/ Ativan 2mg IM

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Acutely agitated
* Requires chemical sedation

Exclusion Criteria

* Physician preference for a specific chemical sedative
* Known allergy to any study medications
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

George Washington University

OTHER

Sponsor Role lead

Responsible Party

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Dept of Emergency Medicine, The George Washington University Medical Center

Locations

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The George Washington University Medical Center, Dept of Emergency Medicine

Washington D.C., District of Columbia, United States

Site Status

Countries

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United States

References

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Brown J. The spectrum of informed consent in emergency psychiatric research. Ann Emerg Med. 2006 Jan;47(1):68-74. doi: 10.1016/j.annemergmed.2005.08.025. Epub 2005 Nov 17.

Reference Type BACKGROUND
PMID: 16387220 (View on PubMed)

Other Identifiers

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010411 (completed)

Identifier Type: -

Identifier Source: org_study_id